Status:
COMPLETED
Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Schwa medico (device lending)
Conditions:
Osteoarthritis
Musculoskeletal Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability. Auricular tran...
Detailed Description
Symptomatic hand osteoarthritis (HOA) affects 8-16% of the general population above 50 years and involves interphalangeal (IP) joints. HOA symptoms include pain, stiffness and are responsible for disa...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Symptomatic HOA according to the American College of Rheumatology criteria
- Erosive HOA according to hand radiographs performed in routine practice showing ≥1 erosive digital joint based on Verbruggen-Veys scoring definition
- Hand pain level ≥ 40/100 mm on VAS at inclusion at least half of days of the 30 last days
- At least ≥1 symptomatic IP joint with clinical soft swelling or erythema at inclusion
- reported inadequate response or adverse effects or contraindication with existing medication (including acetaminophen, oral NSAIDs)
- Informed written consent
- Patient affiliated to a social security scheme NB: Clinical inflammation, ultrasound abnormalities and radiographic erosions have not have to be present in the same joint.
Exclusion
- Isolated thumb-base OA (i.e., rhizarthrosis)
- Predominance of the pain in the thumb base rather than digital pain
- Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, Lyme disease)
- Psoriasis
- Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection, external otitis)
- Ear canal not adapted to apply the auricular electrode
- Known history of cardiac rhythm disturbances, atrio-ventricular block \> first degree, or total bundle branch block
- Symptomatic orthostatic hypotension or repeated vasovagal syncope history
- History of vagotomy
- Severe Asthma
- Treated sleep apnea
- Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
- Fibromyalgia
- Use of other electrically active medical devices (e.g. pacemaker, TENS for chronic pain)
- Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the last 3 months
- Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint.
- Planned hand surgery in the next 3 months.
- Use of any investigational (unlicensed) drug within 3 months prior to screening.
- Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastro-intestinal disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study
- Pregnant or breastfeeding woman
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Use of VNS before the study
- Use of NSAIDs or paracetamol less than 48h before the D0 visit
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04520516
Start Date
April 8 2021
End Date
June 30 2022
Last Update
September 16 2025
Active Locations (1)
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1
Service de Rhumatologie - Hôpital Saint Antoine
Paris, France, 75012